Pharma Regulatory Affairs Resources

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Pharma Regulatory Affairs Resources

Postby Edward » Thu Jan 28, 2016 8:36 pm


I am a Regulatory Affairs Manager at an Agricultural Biotech Company. I am enjoying this work, but it's not the best of times in this sector, and I'm interested in moving to the pharma industry. If anyone could point me towards some resources that would help me to become more knowledgeable, I would really appreciate it. I have a few contacts I can reach out to, but would like to make sure I have the right basic knowledge to ask good questions beforehand.

Thank you!
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Re: Pharma Regulatory Affairs Resources

Postby Dave Jensen » Fri Jan 29, 2016 4:39 pm

Hi Edward,

I work in your field as well. There's a lot of consolidation, loss of jobs and so forth, but it is all restricted to the largest companies. There are a zillion smaller companies, some of them in a real growth mode. I'd suggest you just focus a bit more on your own sector first, because a lateral move over to Pharma could be tricky! Still, its do-able. I just don't want you to toss the baby out with the bath water, as they say. You have an ag background that these companies want, and the smaller companies LOVE people with big company ag regulatory background.

I would suggest you look at the RAPS organization, and their website. It is an industry organization focused on more of the pharma and medical device side of regulatory. Start reading about the government agencies and the way that regulatory process is described in publications like theirs and then you'll feel more confident along the way.

Also, many of the non-profit agriculture for development institutes are moving into new types of crops that need regulatory approvals as well, and those institutes haven't been hit yet with the job loss that the big seed companies have had. There may be prospects there.

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